FDA gives full approval to Pfizer-BioNTech COVID-19 vaccine; AHA, AMA and ANA respond

The Food and Drug Administration today granted full approval for the Pfizer-BioNTech COVID-19 vaccine for individuals age 16 and over. The vaccine, which will now be marketed as Comirnaty, is the first COVID-19 vaccine to go beyond emergency use status in the United States. The vaccine continues to be available under emergency use authorization, including for individuals ages 12 through 15 and for the administration of a third dose in certain immunocompromised individuals.

In a statement shared with the media, the AHA, American Medical Association and American Nurses Association, applauded the FDA approval, saying, “According to recent polling, 30 percent of unvaccinated people said they were waiting for vaccines to receive full approval before getting vaccinated. We are there now; this vaccine is fully approved.” View the full statement from the AHA, AMA and ANA.

Visit the AHA vaccine confidence webpage for a host of resources that can be used and customized, as well as our consumer vaccine webpage that addresses common questions about vaccine use.